Recalls / —
—#134384
Product
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
- FDA product code
- JDR — Staple, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K080088, K101063
- Affected lot / code info
- PN: 110010873 Lot: 209340
Why it was recalled
The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Root cause (FDA determination)
Employee error
Action the firm took
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
Timeline
- Recall initiated
- 2015-02-26
- Posted by FDA
- 2015-04-02
- Terminated
- 2016-01-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #134384. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.